Medical Device Startup Project Management

1. © 2 0 1 7 Y a k a r E n g i n e e r i n g G r o u p A l l R i g h t s R e s e r v e d

2. THE OPPORTUNITY
 Israeli Medical Device Startups in 2016:
The total number of new medical device startups rose to 1,400, of
which about 90 companies established in 2016
69 companies were sold for a total sum of $5.41 billion
 In 2015, investors gained $1.5 from exits for every $1 invested in
new startups
2

3. THE OPPORTUNITY (CONT.)
3

4. THE CHALLENGES
 About 90% of all medical device startups fail
 These failures can often be attributed to mismanagement and
incapability to orchestrate the design project life-cycle, in a time and
budget constraint manner
 The tail wagging the dog syndrome, wherein a design body dictates
the whole design project, sets a time table toward project execution,
while applies his own V&V procedure, in a vehement conflict of
interest manner
4

5. THE CHALLENGES (CONT.)
 Incapability in integrating between all parties involved (e.g.
Entrepreneur, Design House, Advisory Board, Regulatory
Consultant, CRA, etc.) in an efficient and cost-effective manner.
 Lack of adequate and a real-time manner change management,
such as change of material, technology, components, methods,
etc., directly effecting project and product characteristics (e.g.
duration, budget, risk, regulatory classification, etc.) inevitably
creating redesign, project duration setbacks, budget
irregularities, and more.
5

6. THE CHALLENGES (CONT.)
 Executing of overlapped tasks by various parties involved
(e.g. Regulatory Affairs consultant/Clinical Research
Consultant, etc.)
 Failing to address tasks and assignments which merely fall
through the cracks (e.g. Generating Product
Documentation, etc.)
6

7. OUR SOLUTION
We provide first class comprehensive Project Management
services, focused on the entire medical device life-cycle:
 Project Definition
 Product Analysis
 Quality Assurance System
 Design Planning and Management
 Design Execution V&V
 Clinical Research
 Regulatory Affairs
 Transfer to Production (e.g. PRR, FAI, etc.)
 Rollout
7

8. THE PROCESS
 Conduct a comprehensive Current Situation Analysis
 Regulatory Strategy Compilation
 Project Plan Development & Execution (i.e. Milestone, Cost &
Metric Tracking)
 Establishing a FDA 21 CFR Part 820 & ISO 13485 compliant
QMS
 Product Definition & Analysis
 Design Definition & Outsourcing
 Generating Product Documentation (e.g. TF, DMR, DHF, DHR,
etc.)
8

9. THE PROCESS (CONT.)
 Design Monitoring & Management (i.e. Budget, Task Duration, QA,
QC, Compliance with Design Requirements, Standards & Directives,
etc.)
 Conduct a comprehensive Design V&V (e.g. PDR, CDR, ATP, etc.)
fully compliant with IEC 60601, IEC 62304, ISO 109931, ISO 11135,
etc.
 Planning & Executing Clinical Trials, Compliant with EN ISO 14155
 Product Global RA Submission (e.g. US FDA, EU CE, China CFDA,
Canada CMDCAS, etc.)
 Transfer from Design to Production, Planning and Execution PRR &
FAI
9

10. OUR EXPERTISE
 At Yakar Engineering Group, we have nearly 15 years of
experience in the medical device industry, providing
comprehensive project management services for numerous
startup companies in Israel, in the most efficient and cost-
effective manner.
 A team of eminent engineers with a vast engineering and
technological background gained at leading global medical
device companies, by holding senior positions, such as Design
Engineer, QA, RA & CR Director, etc.
10

11. OUR EXPERTISE (CONT.)
 We have extensive contacts throughout the country in all the
major hi-tech hubs, TTO and accelerators such as: Haifa Hi-
Center, Tel Aviv Rad-Bio Med, eHealth, Nazareth NGT3, Mor
Research Application, etc.
 Our practice is distinguished by its team of expert professionals,
native English speakers, who hold advanced degrees in
Mechanical, Biomedical and Electrical Engineering, from world-
class institutions in Israel and North America.
11

12. MULTIDISCIPLINARY EXPERIENCE IN MED-TECH
We have a vast experience in working with various areas of
medical device startups including, but not limited to:
 Medical aesthetics and dermatology (professional & domestic)
 Remote diagnosis technology
 Portable monitoring technology of vital signs (hospital grade)
 Breastfeeding (professional & domestic)
 Liquid medication management & dispensing (hospital grade)
 AED innovation technology
 Rehabilitation technology
 Early stage detection of cancer
12

13. Thank You
Zion Nigel Yakar, M.Sc. BME
Managing Partner at Yakar Engineering Ltd.
E-mail: zion@yakar-eng.co
Mobile: +972-53-6325421
13